iPSC Archives | Page 4 of 19

FDA Grants RMAT to iRegene’s NouvNeu001, Making It World’s First iPSC Therapy with FTD and RMAT Recognitions

February 8, 2026 By BioInformant Team Leave a Comment

Designation underscores potential of chemically induced, off-the-shelf cell therapy to address high unmet need in Parkinson’s disease, following compelling Phase I clinical data

CHENGDU, China, Jan. 19, 2026 — iRegene Therapeutics Co., Ltd. (“iRegene” or the “Company”), a biotechnology company pioneering chemically induced allogeneic cell therapy, today announced that its lead product, NouvNeu001, has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) for the treatment of Parkinson’s disease (PD). [Read more…]

I Peace Announces Successful Generation of Human iPS Cells from NKT Cells and Commences Their Availability

February 6, 2026 By BioInformant Team Leave a Comment

February 6, 2026 – Palo Alto, CA – Leading GMP cell therapy CDMO I Peace, Inc., specializing in induced pluripotent stem cells (iPSCs) and iPSC-derived cell therapies, announced that it has successfully generated human induced pluripotent stem (iPS) cells from NKT cells and has begun offering them for research use. NKT cells are immune cells known to possess characteristics of both innate and adaptive immunity and to play important roles in cancer, infectious diseases, autoimmune disorders, and other conditions. The establishment of iPS cells derived from NKT cells is expected to significantly advance research in regenerative medicine and cancer therapy based on immune mechanisms. [Read more…]

Top iPSC Providers Transforming Preclinical Safety for Big Pharma

February 2, 2026 By BioInformant Team Leave a Comment

The pharmaceutical industry continues to grapple with preclinical and clinical safety issues, with toxicity remaining a leading cause of drug failure. Cardiovascular toxicity, in particular, stands out, accounting for approximately 40% of all drug withdrawals due to safety concerns. To mitigate these risks, human induced pluripotent stem cell-derived cardiomyocytes (iPSC-CMs) have emerged as a critical tool for evaluating cardiac safety. Traditionally, most studies have relied on iPSC-CMs from one or two healthy donors, limiting the representation of broader population variability in drug response. [Read more…]

Lineage Takes Delivery of Genetically Engineered iPSC Line with Hypoimmunity Edits from Factor Bioscience

January 15, 2026 By BioInformant Team Leave a Comment

CARLSBAD, Calif. – Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel allogeneic, or “off the shelf,” cell therapies for serious medical conditions, announced the receipt of a novel, induced pluripotent stem cell (iPSC) line containing hypoimmunity edits, from Factor Bioscience Inc. (“Factor”). Generation of the line marks a successful milestone in the strategic collaboration between the two companies, under which Factor developed a proprietary, genetically engineered iPSC line that Lineage can utilize for differentiation into certain cell transplant product candidates. [Read more…]

Cellistic Launches Three New iPSC-based GMP Manufacturing Platforms to advance Immuno-Oncology and Regenerative Cell Therapies

January 13, 2026 By BioInformant Team Leave a Comment

Belgium, Mont Saint-Guibert, 13 January 2026 – Cellistic, a global leader in allogeneic iPSC-derived cell therapy manufacturing, today announced the launch of three new iPSC-derived GMP cell therapy manufacturing platforms: Echo™-T, Echo™-Cardio, and Echo™-Endothelial. The new platforms are designed to advance cell therapies and drive progress across immuno-oncology and regenerative medicine.Building on the success of the Cellistic Echo™-NK manufacturing platform for natural killer (NK) cells, the expanded Cellistic Echo™ portfolio leverages the company’s GMP manufacturing expertise and its EMA-certified, FDA- and PMDA-compliant manufacturing facility. Through dedicated platform development, these capabilities are extended to deliver scalable solutions across additional immune and regenerative cell types.
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